The Effect of a 30-day Automated Text Messaging Intervention on Hospital Based Acute Care Encounters Following Ileostomy

Ileostomy - Stoma Clinical Trial

Official title:

The Effect of a 30-day Automated Text Messaging Intervention on Hospital Based Acute Care Encounters Following Ileostomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03424954
• Other study ID #: 28262
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2019
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Each year a large number of patients undergo ileostomy surgery, a procedure in which a portion of the small intestine is attached to a hole in the abdominal wall, allowing for digested material to pass into a disposable bag worn attached to the skin. Ileostomies are performed for the treatment of a variety of diseases of the intestinal tract, such as inflammatory bowel disease, intestinal trauma, and gastrointestinal malignancy. Of the patients that undergo ileostomy surgery, 36% will require urgent medical care within the first 30 days of surgery. Most frequently, this is a result of dehydration due to excessive ostomy output. Thus, there is potential for significant improvement of the post-operative outcomes of ileostomy patients. Implementation of an automated text messaging system, EpxOstomy, can provide a way of monitoring patient's daily ostomy output and allow for timely intervention if output is outside normal limits, providing an effective way of improving patient outcomes while simultaneously reducing healthcare costs.

Description:

Each year thousands of patients undergo ostomy surgery in the treatment of diseases such as colorectal cancer, Crohn's disease, diverticulitis, and ulcerative colitis. During the 30-day post-operative period, patients that undergo ileostomy have a 36.1% rate of acute healthcare encounter compared to 16.2% of patients undergoing similar surgery but with primary anastomosis. The 30-day hospital readmission rate for ileostomy patients due to dehydration and renal failure is 17%, with the median cost per colorectal surgery readmission being $8,885. Thus, there is substantial room for post-operative improvement in the care of ileostomy patients, both to reduce healthcare costs and improve patient quality of life. An automated text messaging system can provide a way to consistently monitor patients' ileostomy output, ensuring that patients are measuring their daily output as instructed and allowing for timely preemptive intervention should output be outside normal limits.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients between 18-90 years of age with phone or text receiving device access.

• English speaking

• Patients undergoing ileostomy surgery

Exclusion Criteria:

• Patients who do not have phone or text receiving device access

• Patients mentally unable to provide consent for the study

• Patients who do not speak English

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• Ileostomy - Stoma
• Ileostomy Malfunction
• Ileostomy Underactive
• Ileostomy; Complications

Intervention

Behavioral:
• EpxOstomy
A 30-day post-operative automated text-messaging intervention for home monitoring of ileostomy output

Locations

Country	Name	City	State
United States	SSM Health Saint Louis University Hospital	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
St. Louis University	Epharmix, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Paquette IM, Solan P, Rafferty JF, Ferguson MA, Davis BR. Readmission for dehydration or renal failure after ileostomy creation. Dis Colon Rectum. 2013 Aug;56(8):974-9. doi: 10.1097/DCR.0b013e31828d02ba. — View Citation

Tyler JA, Fox JP, Dharmarajan S, Silviera ML, Hunt SR, Wise PE, Mutch MG. Acute health care resource utilization for ileostomy patients is higher than expected. Dis Colon Rectum. 2014 Dec;57(12):1412-20. doi: 10.1097/DCR.0000000000000246. — View Citation

Wick EC, Shore AD, Hirose K, Ibrahim AM, Gearhart SL, Efron J, Weiner JP, Makary MA. Readmission rates and cost following colorectal surgery. Dis Colon Rectum. 2011 Dec;54(12):1475-9. doi: 10.1097/DCR.0b013e31822ff8f0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital-based acute health care encounters (HBAC)	The percentage of patients that require a HBAC (HBAC = readmissions + emergency department visits) due to post-op complications following ileostomy surgery. Medical records will be reviewed for readmissions or ED visits within 30-days following discharge. Additionally, the final message of the automated text-message intervention asks patients if they required readmission or ED care at any non-Saint Louis University Hospital facility(s).	30 days following discharge
Secondary	Patient response rates	Automated message response data	throughout the 30 days of the intervention
Secondary	Patient satisfaction survey results	Results of a patient survey administered via automated text-message after completion of the intervention.	One time, on day 30 of the intervention.